NUEYNE-T100 Tinnitus Device Combines Vagus Nerve Stimulation and Sound Therapy

[Vadimus]

NUEYNE-T100 is yet another device using both electrical and auditory stimulation, from a Korean company. NU EYNE researches and develops the treatment protocol for tinnitus by combining the approaches of auricular vagus nerve stimulation and sound therapy in synchrony.

NUEYNE-T100 Tinnitus Device Pipeline

Phase I trial results:

Effects of Transcutaneous Trigeminal Electrical Stimulation and Sound Therapy in Patients with Tinnitus

The THI used in this study is one of the most commonly used questionnaires to evaluate the severity of tinnitus symptoms. Previous studies have demonstrated the reliability, validity, and consistency of the THI. The THI consists of 25 items with three subscales (functional, emotional, and catastrophic). In the present study, emotional and catastrophic domains were statistically significantly improved. Among these, catastrophic subscales that have a high correlation with depression, anxiety, somatic symptoms, subjective loudness, and annoyance decrease significantly after TTES.

 

[Tomas80]

What does the timeline in the picture mean? Is the device in the commercialization stage for migraine? If it becomes available for migraine, can I buy it and use it for tinnitus? Is it that simple?

 

[SarahMLFlemmer]

I have overactive bladder, migraines, and tinnitus

...is the study saying the device was only used on people who had tinnitus less than 3 months?

 

[ErikaS]

What does the timeline in the picture mean? Is the device in the commercialization stage for migraine? If it becomes available for migraine, can I buy it and use it for tinnitus? Is it that simple?

If you go to their website, you will see the product for migraine and the product for tinnitus are two completely different products. Each focused area has its own unique product to target the condition.

 

[Nick47]

the study saying the device was only used on people who had tinnitus less than 3 months?

At least 3 months, which to me is too short. That said, many had tinnitus for years as you can see in the table.

What does the timeline in the picture mean? Is the device in the commercialization stage for migraine? If it becomes available for migraine, can I buy it and use it for tinnitus? Is it that simple?

You are assuming the same device will treat all conditions?

 

[Jonno02]

If you go to their website, you will see the product for migraine and the product for tinnitus are two completely different products. Each focused area has its own unique product to target the condition.

The tinnitus device comes with a phone app. Would be nice to be able to change our tonal frequency with this as it appears the Michigan Device can only be changed by practitioners.

 

[Vadimus]

What does the timeline in the picture mean? Is the device in the commercialization stage for migraine? If it becomes available for migraine, can I buy it and use it for tinnitus? Is it that simple?

It's not a great graph, but from what I understand it shows that Phase 1 and 2 clinical trials for their tinnitus device are complete.

I think they have a different device for migraines.

ELEXIR is the treatment device for migraine:
→ https://nueyne.com/en/product/product05.html

BEETHOVEN is the treatment device for tinnitus:
→ https://nueyne.com/en/product/product03.html

 

[El BUZZ]

is the study saying the device was only used on people who had tinnitus less than 3 months?

Participant number 10 of the trial has had tinnitus for 240 months = 20 years.

 

[UHPTS]

Their device looks like it is market ready. Also because it is driven by a phone, new/updated features will be downloadable as soon as they become ready. I assume parameters like tinnitus pitch will be adjustable by a user and there won't be a need to visit the ear doctor to get the device.

This device compared to Dr. Shore's device is like Tesla to most other automakers.

<fingers crossed>

 

[DimLeb]

Judging by its name and its use of the word "neuroplasticity", it looks like it's just another Lenire.

 

[Nick47]

This device compared to Dr. Shore's device is like Tesla to most other automakers.

Yes, but where is the evidence of effectiveness? Loads dropped out of the trial and what about the outcomes?

 

[ErikaS]

Did anyone catch these inconsistencies though? In the study, they show Figure 1 of the device used and explain what was targeted (trigeminal electrical stimulation). The device in the study is like a headset and looks more like the device advertised for other conditions. With what they are advertising as "Beethoven" for tinnitus, it is a completely different device than what was used in the study, AND Beethoven apparently targets auricular vagus nerve stimulation.

So, we have a study with a headset looking device targeting trigeminal nerve stimulation, and then you have an advertised device that is an in-ear device that targets auricular vagus nerve stimulation.

Someone please correct my confusion if I am at all wrong.

 

[Jonno02]

Judging by its name and its use of the word "neuroplasticity", it looks like it's just another Lenire.

It's the same principal as Susan Shore's device; same target nerve. It's thought that maladaptive neuroplasticity is the root of tinnitus, so why wouldn't it also be the answer?

Lenire stimulates an entirely different nerve.

 

[Nick47]

It's the same principal as Susan Shore's device; same target nerve. It's thought that maladaptive neuroplasticity is the root of tinnitus, so why wouldn't it also be the answer?

I thought it was the same target.

Surely we need a bigger 2nd trial before drawing any conclusions.

I wonder how many of these will pop up. 'dr. Shore's device will be left on the shelf at this rate. I think another prototype is in clinical trials at Brai3n currently.

 

[Vadimus]

Did anyone catch these inconsistencies though? In the study, they show Figure 1 of the device used and explain what was targeted (trigeminal electrical stimulation). The device in the study is like a headset and looks more like the device advertised for other conditions. With what they are advertising as "Beethoven" for tinnitus, it is a completely different device than what was used in the study, AND Beethoven apparently targets auricular vagus nerve stimulation.

So, we have a study with a headset looking device targeting trigeminal nerve stimulation, and then you have an advertised device that is an in-ear device that targets auricular vagus nerve stimulation.

Someone please correct my confusion if I am at all wrong.

I too was confused that the device in the study looks nothing like the product on their website.

 

[ErikaS]

I thought it was the same target.

Surely we need a bigger 2nd trial before drawing any conclusions.

I wonder how many of these will pop up. 'dr. Shore's device will be left on the shelf at this rate. I think another prototype is in clinical trials at Brai3n currently.

Like I said above though, what device are we dealing with here. The study one that supposedly targets trigeminal nerve stimulation that looks like a headset device of some kind in figure 1 in the study, or their advertised "Beethoven" that are in-ear devices that target auricular vagus nerve stimulation? Am I the only one seeing this huge discrepancy? Lol.

 

[Jonno02]

Like I said above though, what device are we dealing with here. The study one that supposedly targets trigeminal nerve stimulation that looks like a headset device of some kind in figure 1 in the study, or their advertised "Beethoven" that are in-ear devices that target auricular vagus nerve stimulation? Am I the only one seeing this huge discrepancy? Lol.

The website photo is a 3D render. Looks almost like an artist's impression. Possibly either they don't quite know the final form of the device yet or they don't want to give too much away to potential competition.

The one in the study kinda looked like a pair of glasses to me? At this rate we'll all look like a futuristic person from Back To The Future with our bimodal sunglasses, Michigan headsets and Lenire tongue zappy thing.

 

[Vadimus]

I just emailed NU EYNE and got this answer:

We have 8 indications being investigated for the potential clinical benefits, including tinnitus.

For tinnitus, we will conduct a phase I study in Korea. It will take about three years to be ready for commercialization.

One of the challenges we are facing is with the funding. We are exploring different options to hasten the process.

 

[ErikaS]

I just emailed NU EYNE and got this answer:

Thanks for reaching out. Everything is freaking "3 years away" or more.

 

[GlennS]

 

[ZFire]

The THI used in this study is one of the most commonly used questionnaires to evaluate the severity of tinnitus symptoms. Previous studies have demonstrated the reliability, validity, and consistency of the THI. The THI consists of 25 items with three subscales (functional, emotional, and catastrophic). In the present study, emotional and catastrophic domains were statistically significantly improved. Among these, catastrophic subscales that have a high correlation with depression, anxiety, somatic symptoms, subjective loudness, and annoyance decrease significantly after TTES.

And here lies the problem once more. People believing that these tinnitus questionnaires are valid means to assess the effectiveness of tinnitus treatments...

 

[Vadimus]

Another e-mail from Nu Eyne team. I checked with them about the first study and inquired about the amount of funding needed:

It takes several clinical trials required to have the device registered.

The estimate of funding needed is about 15 million USD, and we will keep you posted if there are any updates to the strategy.